Masterarbeit

Pharmacodynamic data submitted for the marketing authorization of biopharmaceuticals in the European Union ***

Dr. Katrin Motejlek (2015)

Summary
Language: English
Biopharmaceuticals or biologics represent a quantum leap in medical science and have revolutionized the therapy of many diseases or made it possible in the first place. They are high-tech medicinal products generated artificially by recombinant DNA technology that are produced in genetically modified microorganisms, cells or animals for use in the treatment, diagnosis or prevention of severe or rare diseases. They are either used as substitutes that conform completely or for the most part to endogenous proteins compensating their deficiencies or they affect various body functions and exert pharmacological effects during the treatment of the disease. Most of the marketed biopharmaceuticals are large proteins whose efficacy is linked to their correct three-dimensional structure. But also much smaller products like peptides are available today.
The selected categories of biopharmaceuticals and indication areas as well as active substances and endogenous molecules presented in this thesis give a brief overview of the current therapeutic situation and available pharmacodynamic data as well as an indication of future possibilities. Described in detail are the following six categories of biopharmaceuticals: monoclonal antibodies/antibody fragments/hybrid molecules, hormones and growth factors, enzymes, anticoagulants and thrombolytics, immunological mediators and modulators, nucleic acids and antisense oligonucleotides with focus on primary and secondary pharmacodynamics, safety pharmacology and drug interactions during preclinical evaluation as well as on pharmacodynamic parameters investigated either in clinical pharmacodynamic or combined clinical pharmacokinetic/pharmacodynamic studies.
Pages: 59